UMIN-CTR Clinical Trial

Basic information
Public title	Examination of bowel movement improving effect of yogurt
Acronym	Examination of bowel movement improving effect of yogurt
Scientific Title	Examination of bowel movement improving effect of yogurt
Scientific Title:Acronym	Examination of bowel movement improving effect of yogurt
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Ingest yogurt for 2 weeks in adult men and women who are aware of constipation, and examine whether or not there is improvement in bowel movements after ingestion.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Compare the number of defecations in the week before ingestion with the number of defecations in the week from 1 week after ingestion to 2 weeks after ingestion.
Key secondary outcomes	Compare the stool properties for 1 week before ingestion with the stool properties for 1 week from 1 week after ingestion to 2 weeks after ingestion.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake yogurt for 2 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subjects who have received sufficient explanation about the purpose and contents of this examination, have the ability to consent, fully volunteered with voluntary intention, agreed to participate in the document. (2) Subjects with an average of 4 or less bowel movements per week. (3) Subjects who have agreed to account registration for the smartphone app "Unlog", subjects who have already registered for an account.
Key exclusion criteria	(1) Subjects with chronic medical illness or a history of serious illness. (2) Subjects with underlying disease that causes chronic constipation, subjects with a history of gastrointestinal surgery. (3) Subjects who do not have a dietary habit of 3 meals a day. (4) Subjects with food allergies. (5) Subjects with lactose intolerance. (6) Subjects who took fermented milk such as yogurt, lactic acid bacteria drink, and natto at least 4 times a week during the month before the SCR test. (7) Subjects taking medications or quasi-drugs that may affect the study at least once a week, or subjects taking health foods at least four times a week, or subjects taking health foods four or more times a week during the month prior to the SCR test, or Subjects who plan to use these at least once during the study. (8) Subjects who have undergone gastroscopy, gastric X-ray barium, colonoscopy, colon cleansing or stool removal during the month prior to SCR, or during this study. (9) Subjects with or may have or have a history of IBS / organic constipation. (10) Subjects who participated in or plan to participate in other studies except observational studies during the month prior to the SCR test. (11) Women with changes in bowel movements during menstruation. (12) Pregnant subjects, subjects planning to become pregnant during the study period. (13) Breastfeeding subjects. (14) Smokers or subjects who quit smoking for less than 3 months. (15) Subjects who drink much alcohol. (16) Subjects who plan to move with night shifts or accommodation. (17) Subjects who are judged as ineligible by the clinical investigator.
Target sample size	22

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Nakamura
Organization	Urban heights clinic
Division name	None
Zip code	170-0002
Address	1-16-2 sugamo, toshima-ku, Tokyo, Japan
TEL	03-3946-6721
Email	ucl6721@sepia.ocn.ne.jp

Public contact
Name of contact person	1st name Shinsuke Middle name Last name Tsuji
Organization	EP Mediate Co., Ltd.
Division name	Development Business Headquarters, TTC Center, Trial Planning Department
Zip code	162-0822
Address	Tsuruya Bldg., 2-23 Shimomiyabicho, Shinjuku-ku, Tokyo
TEL	03-5657-4983
Homepage URL
Email	tsuji472@eps.co.jp

Sponsor
Institute	EP Mediate Co., Ltd.
Institute
Department

Funding Source
Organization	Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	saito876@eps.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団 絆 アーバンハイツクリニック/Urban heights clinic

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 03 Month 25 Day
Date of IRB	2021 Year 03 Month 25 Day
Anticipated trial start date	2021 Year 04 Month 18 Day
Last follow-up date	2021 Year 06 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 12 Day
Last modified on	2021 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050138